Objective
ALFOTAM is a Sanofi-Synthelabo Inc. trial; the data are available on the Food and Drug Administration Web site. A multicenter, multinational, randomized, placebo-controlled, double-blind, phase III trial, ALFOTAM assessed the efficacy and safety of two dosage levels of alfuzosin Geomatrix (10 mg OD* and 15 mg OD*) vs tamsulosin 0.4 mg and placebo in patients with symptomatic BPH. (Learn more about the design of this trial.)1
Results
The number of adverse events was low across all study groups and placebo. Ejaculation failure was experienced by only two patients (1.3%) in both the alfuzosin 10-mg group and the tamsulosin 0.4-mg group. In the tamsulosin 0.4-mg group, <2% of patients experienced ejaculation disorder.1
The incidence of syncope, hypotension and malaise was also low across all study groups and placebo. However, dizziness occurred in almost 6% of patients in the alfuzosin 10-mg group, in 7% of patients in the alfuzosin 15-mg group and in almost 4% of patients in the placebo group. In the tamsulosin 0.4-mg group, <2% of patients experienced dizziness.1
*OD=once daily.
See the efficacy results from the ALFOTAM Trial
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Talking with your patients about BPH |
Important Safety Information
FLOMAX is indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension. As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. Patients beginning treatment with FLOMAX should be cautioned to avoid driving or hazardous tasks for 12 hours after their first dose or increase in dose should syncope occur. The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
Caution should be exercised with concomitant administration of warfarin and FLOMAX. In addition, FLOMAX should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg. FLOMAX is contraindicated in patients known to be hypersensitive to tamsulosin HCl or any component of FLOMAX.
Before prescribing FLOMAX, please see the full Prescribing Information.
1. Center for Drug Evaluation and Research. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/foi/nda/2003/021287_uroxatral_toc.htm. Accessed July 12, 2006.
